Methods Of Dulaglutide Purification Using Hydrophobic Interaction Chromatography

Abstract: The present disclosure is directed to methods of purifying a dulaglutide composition. For example, the methods comprise loading the dulaglutide composition in-line with a buffer B solution onto a hydrophobic interaction chromatography (HIC) column in a downflow direction, washing the HIC column with a buffer mixture of a buffer A solution and the buffer B solution in the downflow direction, and eluting dulaglutide from the HIC column. A linear gradient of a percentage of the buffer A and buffer B solutions is used for eluting dulaglutide, which is then followed by an isocratic hold based on a UV absorbance reading of an eluate. The methods further comprise maintaining the isocratic hold until a front side cut is made, and then dropping the buffer B solution for dulaglutide to elute from the HIC column.

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